Clinical Study of VG161 Combined With Nivolumab Injection in Patients With Advanced Metastatic Gastric Cancer

Sponsor
CNBG-Virogin Biotech (Shanghai) Ltd.
Study ID
NCT06008925
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) — DRUG
    Intratumoral injection only. Dosing days may be Day 1 or Days 1-3 only.
  • Nivolumab Injection — DRUG
    Administered once at 3 mg/kg intravenously on Days 8 and 22 of each cycle.

Study Details

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 injection. This study will be conducted in combination with nivolumab injection in HSV seropositive subjects with advanced metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic treatment regimens (which must include anti-PD-1 monoclonal antibodies). This is an open-label study divided into two parts. Part 1: This part is an escalating dose trial to explore the safety of the combination and determine the recommended safe dose of the combination. Part 2: This part is an extension trial to investigate the preliminary efficacy of the combination at a safe dose.

Key Dates

Start date
Nov 17, 2022
Status verified
Aug 2023
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Part1: VG161: 1\) 1.0 × 10 \^ 8 PFU daily on Day 1 of each cycle (D1); 2)1.0 × 10 \^ 8 PFU daily for 2 consecutive days on Days 1-2 of each cycle (D1-D2); 3)1.0 × 10 \^ 8 PFU daily for 3 consecutive days on days 1-3 (D1-D3) in the first cycle; 1.0 × 10 \^ 8 PFU daily for 2 consecutive days on days 1-2 (D1-D2) in the second and subsequent cycles; Nivolumab Injection: 3 mg/kg every 2 weeks (D8, D22) Part2: Depends on the recommended dose in Part1

Primary Outcome Measure

Phase Ib:RP2D/MTD [ Time Frame: through Phase Ib study completion, an average of 1 year ]

Central Contacts

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